Clinical trials: Liver Transplant Infection
Hepatitis B
A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.
- Trial name
- NCT01513850
- Testing
- Hepabulin IV
- Where
- South Korea
- Volunteers
- 87 people
- Sponsor
- SK Chemicals Co., Ltd.
Hepatitis B Infection
HBV-associated Liver Transplant(LT) Patients by IV Injecting GC1102
This is a clinical study for GC1102 to demonstrate preventing the recurrence of hepatitis B virus (HBV) infection following liver transplantation and a dose-finding study to determine its optional dose.
- Trial name
- NCT03519113
- Testing
- GC1102 80,000 IU, GC1102 100,000 IU, I.V HBIG
- Where
- South Korea
- Volunteers
- 186 people
- Sponsor
- Green Cross Corporation
Healthy
A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs
The study purpose is to evaluate the potential for a pharmacokinetic drug-drug interaction, safety and tolerability when Narlaprevir, Ritonavir (used as a metabolic inhibitor) and Tenofovir disoproxil fumarate (part 1) and…
- Trial name
- NCT03537404
- Testing
- Narlaprevir, Ritonavir, Tenofovir Disoproxil Fumarate
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- R-Pharm
Liver Transplantation, Mycoses
Liver Transplant European Study Into the Prevention of Fungal Infection
Prevention of invasive fungal infection in high risk patients following liver transplant.
- Trial name
- TENPIN (NCT01058174)
- Testing
- micafungin, fluconazole, liposomal amphotericin B
- Where
- 36 sites in Austria, Belgium and 12 more
- Volunteers
- 350 people
- Sponsor
- Astellas Pharma Inc
Chronic Hepatitis B
Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine (FTC)/TDF, and Entecavir (ETV) in the Treatment of Chronic HBV in Subjects With Decompensated Liver Disease.
This study was designed to evaluate and compare the safety and tolerability of tenofovir disoproxil fumarate (TDF), emtricitabine (FTC)/TDF, and entecavir (ETV) in the treatment of hepatitis B patients with decompensated liver…
- Trial name
- NCT00298363
- Testing
- Tenofovir disoproxil fumarate (tenofovir DF; TDF), Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), Entecavir (ETV)
- Where
- 38 sites in United States, Canada and 9 more
- Volunteers
- 112 people
- Sponsor
- Gilead Sciences
Hepatitis B, Hepatitis C
Observational Study on Prevalence of Host and Viral Genotypes in Chronic Hepatitis B and Hepatitis C Patients in India
This study will define the substantial disease burden associated with viral hepatitis in India, and provide a foundation to understand the host and viral determinants of disease pathogenesis that may ultimately impact treatment…
- Trial name
- NCT01772121
- Where
- 19 sites in India
- Volunteers
- 1,000 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis C Infection
A Study to Evaluate Chronic Hepatitis C Infection in Adult Transplant Recipients
The purpose of this study is to evaluate the safety and efficacy of ABT-450/r/ABT-267 with or without ABT-333 and with or without ribavirin (RBV) in adult liver or renal transplant recipients with hepatitis C virus (HCV) genotype…
- Trial name
- CORAL-I (NCT01782495)
- Testing
- ombitasvir/paritaprevir/ritonavir and dasabuvir, ombitasvir/paritaprevir/ritonavir, ribavirin
- Volunteers
- 129 people
- Sponsor
- AbbVie
Chronic Hepatitis B
A Study of Sequential Therapy With AHB-137 Injection Followed by TVAX-008 Injection in Participants Living With Chronic Hepatitis B (CHB)
This is a study of sequential therapy with AHB-137 injection followed by TVAX-008 injection in participants living with Chronic Hepatitis B (CHB).
- Trial name
- NCT07897448
- Testing
- AHB-137, TVAX-008
- Volunteers
- 105 people
- Sponsor
- Grand Theravac Life Sciences (Hangzhou) Co., Ltd.
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the…
- Conditions
- Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications, Lymphoproliferative Disorders, Allogeneic Hematopoietic Cell Transplant
- Trial name
- ALLELE (NCT03394365)
- Testing
- tabelecleucel
- Where
- 71 sites in United States, Australia and 7 more
- Volunteers
- 115 people
- Sponsor
- Pierre Fabre Medicament
Hepatitis C, Chronic
Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection
This study was designed to assess the safety and efficacy of multiple interferon-free treatment regimens of sofosbuvir (Sovaldi™; GS-7977; PSI-7977) and GS-0938 (PSI-352938) alone and in combination, with and without ribavirin…
- Trial name
- QUANTUM (NCT01435044)
- Testing
- Sofosbuvir, GS-0938, RBV
- Where
- 44 sites in United States, Puerto Rico
- Volunteers
- 239 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis C, HCV
A Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients With Chronic Hepatitis C Virus (MAGELLAN-2)
The purpose of this study is to assess the safety and efficacy of 12 weeks of treatment of ABT-493/ABT-530 (glecaprevir/pibrentasvir) in adults who are post primary orthotopic liver or renal transplant with chronic hepatitis C…
- Conditions
- Chronic Hepatitis C, HCV, Hepatitis C Virus
- Trial name
- NCT02692703
- Testing
- glecaprevir/pibrentasvir
- Volunteers
- 100 people
- Sponsor
- AbbVie
Chronic Hepatitis B
Rollover Protocol Continued Access to Emtricitabine/Tenofovir Disoproxil Fumarate for Adults in United States
The objective of this study is to provide open label emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for an additional 5 years (240 weeks) to adults completing study GS-US-203-0107.
- Trial name
- NCT00936715
- Testing
- FTC/TDF
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus Infection
Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor
The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of…
- Trial name
- POLARIS-4 (NCT02639247)
- Testing
- SOF/VEL/VOX, SOF/VEL
- Where
- 78 sites in United States, Australia and 6 more
- Volunteers
- 333 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Participants With Chronic Hepatitis B Virus (HBV) Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF)-containing regimens at Week 24 in participants with chronic…
- Trial name
- NCT02862548
- Testing
- TAF, TDF, Other approved antivirals
- Where
- New Zealand
- Volunteers
- 51 people
- Sponsor
- Gilead Sciences
Hepatitis C, Liver Transplantation
Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in Hepatitis C Virus (HCV) Positive Liver Transplant Patients
This is an exploratory study to evaluate the impact of eliminating steroid administration upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in patients transplanted for HCV cirrhosis.
- Trial name
- CHASE (NCT00295607)
- Testing
- Tacrolimus, steroids, monoclonal anti-IL2R antibody
- Where
- 17 sites in Czechia, France and 6 more
- Volunteers
- 138 people
- Sponsor
- Astellas Pharma Inc
Cirrhosis
Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Cirrhotics
The three objectives of this trial are: 1. To demonstrate that a decline in hepatic metabolic function as measured by BreathID will correlate with changes in CTP and MELD scores in patients with cirrhosis. 2.
- Trial name
- NCT00375011
- Where
- 3 sites in United States, Israel
- Volunteers
- 200 people
- Sponsor
- Meridian Bioscience, Inc.
Liver Transplantation, Infection
Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids
Systemic infection is still a major concern in young children with liver transplantation. The approach of this study is to reduce the risk of systemic infections by avoiding intraoperative steroids (another class of…
- Trial name
- NCT00149890
- Testing
- Basiliximab, Cyclosporine/cyclosporine microemulsion, Steroid
- Where
- Germany
- Volunteers
- 77 people
- Sponsor
- Novartis
Chronic Hepatitis B
Lamivudine Plus Interferon Versus Lamivudine For The Treatment Of HBeAg Positive Chronic Hepatitis B Virus (HBV)
This is a single-centre prospective randomised study comparing the virological and histological response of HBV infection to lamivudine in combination with interferon versus lamivudine alone.
- Trial name
- NCT00140725
- Testing
- Lamivudine plus Polyethylene glyco-interferon alfa-2b, Lamivudine
- Where
- Hong Kong
- Volunteers
- 160 people
- Sponsor
- GlaxoSmithKline
Hepatitis B
Registry Study for Patients With Chronic HBV Receiving Nucleotide Therapy
This registry will remain open for approximately 5 years (4 years of enrollment + 1 year of follow up). Subjects will be followed until Orthotopic Liver Transplant (OLT), resolution of liver decompensation, death, or conclusion…
- Trial name
- NCT01590615
- Testing
- Anti-HBV nucleoside/nucleotide therapy
- Where
- 27 sites in United States, Canada
- Volunteers
- 54 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic, Healthy Volunteer
A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis C
This 2-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of RO5428029 in healthy volunteers and patients with hepatitis C infection.
- Trial name
- NCT01371162
- Testing
- RO5428029
- Where
- 6 sites in France, Netherlands and 1 more
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche